The Apple iPhone broke new ground in offering an all in one device for Music, Phone, Games, Organizer and general applications. Other companies had introduced almost all the concepts. It was Apple that brought them all together so effectively.
I have considered the suitability of the iPhone specifically as a device for capturing clinical trial data. The obvious application is an eDiary device. People familiar with the iPhone will be aware of the phenomenal success of the App Store. It may be possible to write an eDiary app. However, there are challenges with metadata deployment and application patching that might prove insurmountable given the restrictions that Apple place in deployment. As far as using the native browser on the iPhone – the form factor is just not that suitable. Yes – you can fill in a browser based form, you can do the 2 fingered pan and zoom. But, it just doesn’t quite fly when it comes to regular data entry operations.
Shortly, Apple will release the iPad. In many ways this is like an iPhone or iTouch, but larger. Form factor wise, it is similar to many Tablet PC’s. However, it has the advantage of being tied to the iPhone/iTouch OS. It will also be provided with both Wifi and 3G connectivity.
One of the real boundaries to eSource in clinical trials is the portability and availability of the device at the appropriate times. With the larger touch screen of the iPad and the option of connectivity with either 3G or Wifi, it will be increasingly possible to efficiently capture data at the place of data availability.
So – could the iPad break the capture to paper / transpose to EDC bottleneck at the sites? I think so. The solution is likely to be browser based though – App deployment is still too restrictive. It needs to be fully touch screen friendly. It needs to make it beautifully easy for an investigator to ‘interview’ a patient, and key the data during the interview where appropriate. It needs to provide a means for the investigator to indicate through a simple highlighter pen style UI metaphor that data is being entered as source, or, being transposed from source.
I appreciate that other devices exist today that perform a similar function, but, I believe the connectivity, general ease of use, and low price point will make the iPad stand out.
One critical feature may be the Electronic Health Records link. I think the data that should be copied needs to be at the discretion of the site personnel. I am not yet convinced that data privacy together with a sponsor controlling the study build / data propagation is viable right now. A really simply copy/paste mechanism might be better than nothing in the time being. We will need to see how well the Safari browser performs.
Initially, I see the iPad making inroads within Phase I units. Hardware device interfacing is less of an issue here now – most devices should be looking at centralizing the data interchange, rather than sending it directly to the data entry device. Web 2.0 interactive technologies will allow developers to create some of the realtime functionality that dedicated Phase I solutions have enjoyed in the past.
I am looking forward to seeing the first iPad EDC demonstrations at the DIA in June!